Director of Quality Assurance & Control
Job Description
Job Description
*This is an on-site role based in Wilmington, MA. We are seeking candidates who are already located within commuting distance; relocation support is not provided*
Director of Quality Assurance & Control
???? Lead Quality at the Forefront of Nuclear Medicine
Eckert & Ziegler Radiopharma, Inc. (EZRI) is expanding its U.S. radiopharmaceutical manufacturing and CMO operations in Wilmington, MA — including the build-out and qualification of a new Lu-177 production capability that will directly support advancements in targeted cancer therapies.
We are seeking a highly capable, hands-on Director of Quality to lead QA, QC, validation oversight, and quality systems within a regulated cGMP environment.
This is not a maintenance role. It is an opportunity to shape and strengthen Quality during a critical phase of growth in one of the most dynamic sectors of modern medicine.
The Opportunity
The Director of Quality Assurance & Control will report directly to the General Manager and serve as a key member of the site leadership team. This role partners closely with the Director of Site & CMO Operations, Radiation Safety Officer, QC Manager, and cross-functional leaders to ensure compliant, coordinated execution of site priorities.
This is a highly hands-on leadership position. A visible, consistent presence on the manufacturing floor, in cleanrooms, and within daily operations is expected. The Director of Quality will actively engage with production, QC, and operations teams to ensure real-time quality oversight and decision-making — not operate solely from behind a desk.
A major near-term priority is supporting the Lu-177 facility expansion from a Quality standpoint, including equipment receipt, IQ/OQ/PQ oversight, cleanroom and facility qualification, and process validation.
This role is ideal for a leader who thrives in growth environments and wants to build something meaningful — not simply inherit a static system.
Key Responsibilities
Quality Leadership & Operational Engagement
• Lead and manage site QA and QC functions
• Maintain and strengthen the site Quality Management System (QMS)
• Maintain strong, visible presence within manufacturing and laboratory operations
• Provide real-time quality oversight and decision-making support on the production floor
• Ensure compliance with FDA cGMP regulations (21 CFR Parts 210/211) and applicable regulatory standards
• Oversee deviation investigations, CAPA, change control, and risk management processes
• Ensure inspection readiness and lead regulatory and customer audits
• Partner with site leadership to align quality strategy with operational execution
Equipment & Facility Qualification
• Provide Quality oversight and approval of equipment qualification activities (IQ/OQ/PQ)
• Support qualification of Lu-177 expansion areas, cleanrooms, utilities, and critical systems
• Review and approve qualification protocols and reports
• Ensure validation documentation meets regulatory expectations
• Partner cross-functionally during equipment receipt, commissioning, and qualification to ensure compliant execution
Process Validation & Sterile Manufacturing
• Oversight of process validation and continued process verification
• Ensure method validation and QC laboratory readiness
• Oversee batch record review and batch disposition release processes
• Provide Quality oversight for isotope manufacturing and CMO operations
• Ensure compliance within sterile, cleanroom-based manufacturing environments
• Monitor aseptic practices and environmental controls to ensure sustained compliance
Qualifications
• Bachelor’s degree in a scientific discipline; advanced degree preferred
• 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing.
• Demonstrated QA/QC leadership experience in a cGMP-regulated environment
• Direct experience supporting equipment qualification and process validation programs
• Strong experience in sterile manufacturing and cleanroom operations
• Strong working knowledge of FDA cGMP regulations and inspection readiness practices
• Experience supporting facility expansion or manufacturing build-outs strongly preferred
• Radiopharmaceutical experience preferred
Work Structure
• On-site in Wilmington, MA
• Hands-on, floor-engaged leadership role
• Reports directly to the General Manager
• Serves as a core member of the site leadership team
Why Join EZRI?
• Lead Quality during a transformative Lu-177 manufacturing expansion
• Contribute directly to advancements in nuclear medicine and targeted cancer therapy
• Operate in a collaborative, mission-driven environment where leadership is accessible and engaged
• Shape quality systems that support real growth — not just maintenance
• Competitive compensation, annual bonus eligibility, and comprehensive benefits
If you are a cGMP Quality leader who values operational engagement, disciplined execution, and meaningful impact in healthcare, we welcome the opportunity to connect.